Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact.

BACKGROUND & AIMS: Sarcopenia is a multifactorial syndrome resulting in a decrease in both muscle mass and function. Little is known about the prevalence and prognostic impact of sarcopenia in patients with acutely decompensated chronic heart failure (ADHF). We aimed to evaluate the prevalence (main endpoint) and impact of sarcopenia on ADHF patients. METHODS: 140 ADHF patients were enrolled between November 2014 and September 2018 in a multicenter prospective longitudinal study. A similar, independent multi-departmental cross-sectional study in 165 ADHF patients was used for external validation of prevalence data. All subjects were assessed on the European Working Group on Sarcopenia criteria. RESULTS: Ninety-one patients (65%) had sarcopenia (vs. 53.6% in the external replication regional cohort). Patients with sarcopenia were older and more likely to have eGFR <60 ml/min/1.73 m2 (p < 0.001 and p = 0.002). Sarcopenia was associated with impaired functional status [lower 6 min walking test (220 ± 108 vs. 279 ± 170, p = 0.03) and 4 m gait speed (0.56 ± 0.24 vs. 0.80 ± 0.37, p < 0.001)] and autonomy [Instrumental activities of daily living: 6.7 ± 1.4 vs. 7.3 ± 1.2, p = 0.005]. Over up to 4 years' follow-up, 30 cardiovascular (CV) deaths and 42 non-CV deaths occurred. In a multivariable analysis, sarcopenia was associated with time to first non-CV hospitalization (hazard ratio 1.93; 95% confidence interval 1.14-3.24; p = 0.014) but not with any other hospitalization, any mortality endpoint, or a composite endpoint of CV death and HF hospitalization. CONCLUSIONS: The prevalence of sarcopenia in ADHF patients is high and associated with greater risk of non-CV hospitalizations, highlighting the importance of identifying and managing the condition in a multidisciplinary approach. CLINICAL TRIAL REGISTRATION: NCT03153774.

Factors associated with delay in transfer of patients with ST-segment elevation myocardial infarction from first medical contact to catheterization laboratory: Lessons from CRAC, a French prospective multicentre registry.

BACKGROUND: It is critical to minimize the time between the first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. AIMS: To identify factors associated with a delay of>120min between first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. METHODS: Data were analysed from a regional French registry of patients undergoing coronary angioplasty for ST-segment elevation myocardial infarction<24h after symptom onset. Patients (n=2081) were grouped according to transfer times from first medical contact to primary percutaneous coronary intervention:>120min; or≤120min. Independent predictors of delay were identified by univariate and multivariable analyses. RESULTS: The median transfer time from first medical contact to primary percutaneous coronary intervention was 112min; 892 patients (42.9%) had a transfer time>120min. A delay of>120min was significantly associated with:≥75km distance from interventional cardiology centre at symptom onset (odds ratio 7.9); more than one medical practitioner involved before interventional cardiology centre (odds ratio 4.5); first admission to a hospital without an interventional cardiology centre (odds ratio 2.9); absence of emergency call (odds ratio 1.6); ≥90min between symptom onset and first medical contact (odds ratio 1.3); Killip class at admission>1 (odds ratio 1.8); lateral ischaemia (odds ratio 1.8); diabetes mellitus (odds ratio 1.6); and hypertension (odds ratio 1.3). CONCLUSIONS: In ST-segment elevation myocardial infarction, a transfer time from first medical contact to primary percutaneous coronary intervention of>120min was associated with geographic, systemic and comorbid factors, several of which appear reasonably actionable.

Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis.

OBJECTIVE: To assess safety, tolerability, and efficacy of the antigen-specific immunotherapy ATX-MS-1467 in participants with relapsing multiple sclerosis using different treatment protocols to induce tolerance. METHODS: Two open-label trials in adult participants with relapsing multiple sclerosis were conducted. Study 1 was a multicenter, phase 1b safety evaluation comparing intradermal (i.d.) (cohort 1) with subcutaneous (cohort 2) administration in 43 participants. Both cohorts received ATX-MS-1467 dosed at 25, 50, 100, 400, and 800 µg at 14-day intervals over 8 weeks, followed by 8 weeks with 4 additional 800-µg doses at 14-day intervals and 32 weeks off study medication. Study 2 was a phase 2a, multicenter, single-arm trial enrolling 37 participants. ATX-MS-1467 was titrated from 50 µg i.d. on day 1 to 200 µg on day 15 and 800 µg on day 29 followed by biweekly administration of 800 µg for 16 weeks and 16 weeks off study medication. Efficacy was evaluated on MRI parameters and clinical variables. Safety endpoints included treatment-emergent adverse events and injection-site reactions. RESULTS: In study 1, there was a significant decrease in new/persisting T1 gadolinium-enhanced (GdE) lesions in cohort 1 from baseline to week 16, returning to baseline values at week 48. In study 2, the number of T1 GdE lesions were significantly reduced on treatment and remained reduced at study completion. Safety results were unremarkable in both studies. CONCLUSION: Relatively slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions and a sustained effect post treatment. Further trials of ATX-MS-1467 are warranted. CLASSIFICATION OF EVIDENCE: This work provides Class IV evidence that for patients with relapsing multiple sclerosis, slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions.

Differentiation and phylogenetic relationships in Mycobacterium spp with special reference to the RNase P RNA gene rnpB.

The rnpB gene encodes for the RNA subunit of the catalytic ribonuclease RNase P and is present in all bacteria and has both conserved and highly variable sequence regions. Determination of rnpB in 35 Mycobacterium spp. showed species specific sequences for all species except the Mycobacterium tuberculosis complex (four species). High sequence variation was seen in the P3, P15 and P19 regions of suggested secondary structures of the corresponding RNase P RNA molecules. Phylogenetic analysis showed that rnpB gave similar tree topologies as 16S rRNA and hsp65 genes. A combined analysis of the three genes increased the number of nodes with significant support from 10 to 19. The results indicate that rnpB is useful for phylogenetic studies and is a possible target for identification and detection of Mycobacterium spp.

Structured syncope care pathways based on lean six sigma methodology optimises resource use with shorter time to diagnosis and increased diagnostic yield.

AIMS: To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines. METHODS: Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four. RESULTS: With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests. CONCLUSIONS: Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield.

The lesson of Monsieur Nouma: effects of a culturally sensitive communication tool to improve health-seeking behavior in rural Cameroon.

OBJECTIVE: To test the effect of patient counseling using educational tools, on rates of return for follow-up in newly diagnosed hypertensive and/or diabetic patients in a rural African context. METHODS: Free screening for hypertension and elevated blood glucose was offered in primary health care centers in central Cameroon during 9 campaigns of 3 days each. Individuals with untreated hypertension and/or diabetes were divided into 2 groups: a control group receiving counseling according to routine procedures, and an intervention group receiving counseling with different educational tools to explain the diagnosis and its implications to the patient. RESULTS: Prevalence of hypertension and/or diabetes in the screened population was 41%. At 3 months from screening, rates of return visits were higher in the intervention group than in the control group: 55/169 (32%) vs. 15/92 (16%), OR 2.4; 95%CI 1.3-4.7; p<0.001. CONCLUSION: Screening may identify untreated individuals efficiently. Rates of return visits after screening, although low in both groups, could be doubled by a short communication intervention. PRACTICE IMPLICATIONS: This study suggests that modest communication interventions, e.g., the application of educational tools, may bring important benefits and increase the effectiveness of public health measures to combat chronic diseases in settings of limited resources.

Effectiveness of the homeopathic preparation Zeel compared with carprofen in dogs with osteoarthritis.

The authors compared the symptomatic effectiveness of a complex homeopathic preparation Zeel (1-3 tablets orally per day depending on body weight) to carprofen (4 mg/kg body weight) in dogs (n=68) aged >1 yr diagnosed with osteoarthritis in a multicenter, prospective, observational open-label cohort study in 12 German veterinary clinics. The active treatment period was 56 days. Symptomatic effectiveness, lameness, stiffness of movements, and pain on palpation were evaluated by treating veterinarians and owners. Clinical signs of osteoarthritis improved significantly (P<0.05) at all time points (days 1, 28, and 56) with both therapies. At the end of the treatment period, effectiveness was comparable in both groups. Both treatment regimens were well tolerated with only three treatment-related adverse events, all in the carprofen group.

Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry.

AIMS: To collect information on the use of the Reveal implantable loop recorder (ILR) in the patient care pathway and to investigate its effectiveness in the diagnosis of unexplained recurrent syncope in everyday clinical practice. METHODS AND RESULTS: Prospective, multicentre, observational study conducted in 2006-2009 in 10 European countries and Israel. Eligible patients had recurrent unexplained syncope or pre-syncope. Subjects received a Reveal Plus, DX or XT. Follow up was until the first recurrence of a syncopal event leading to a diagnosis or for ≥1 year. In the course of the study, patients were evaluated by an average of three different specialists for management of their syncope and underwent a median of 13 tests (range 9-20). Significant physical trauma had been experienced in association with a syncopal episode by 36% of patients. Average follow-up time after ILR implant was 10±6 months. Follow-up visit data were available for 570 subjects. The percentages of patients with recurrence of syncope were 19, 26, and 36% after 3, 6, and 12 months, respectively. Of 218 events within the study, ILR-guided diagnosis was obtained in 170 cases (78%), of which 128 (75%) were cardiac. CONCLUSION: A large number of diagnostic tests were undertaken in patients with unexplained syncope without providing conclusive data. In contrast, the ILR revealed or contributed to establishing the mechanism of syncope in the vast majority of patients. The findings support the recommendation in current guidelines that an ILR should be implanted early rather than late in the evaluation of unexplained syncope.

Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008.

AIMS: Heart failure (HF) patients increasingly receive device therapy, either an implantable cardioverter defibrillator (ICD) or a biventricular pacemaker, also called cardiac resynchronization therapy (CRT), or a CRT device with an ICD (CRT-D). However, epidemiological data on the use of device therapy in Europe are limited. METHODS AND RESULTS: Data on implantation rates for conventional pacemakers, ICD, CRT, and CRT-D in 15 Western European countries were obtained from the Eucomed Registry for the 5-year period 2004-2008. Implantation of conventional pacemakers increased by 9% in Europe over the 5 years (reaching 907/million in 2008) and there were significant differences between countries. Implantable cardioverter defibrillator implantations increased by 75% from 80/million in 2004 to 140/million in 2008, and differences between countries were larger than those for conventional pacemakers. Implantation rates for CRT-P alone increased slightly from 2004 to 2006, but remained at 25/million thereafter in Europe overall. The total number of CRT implants (CRT-P and -D) markedly increased from 46/million in 2004 to 99/million in 2008 (115%), but this was mainly due to more CRT-D implants, i.e. an increase in the proportion of CRT-D (from 55% in 2004 to 75% in 2008). Implantation rates for ICD, CRT, and CRT-D remained markedly different throughout the study period between countries. CONCLUSION: Implantation rates of devices for HF, in particular ICD and CRT-D, have increased significantly between 2004 and 2008 in Europe, but there remain major differences between countries.

Estudo nacional, multicêntrico, aberto, randomizado e comparativo para avaliar a eficácia e tolerabilidade da combinação de valsartana e anlodipino versus anlodipino isoladamente no tratamento da hipertensão arterial leve a moderada / A national, multicentric, open label, randomized, and comparative study to evaluate

Este estudo avaliou os efeitos na redução da pressão arterial(PA) da combinação de valsartana 80 mg mais anlodipino 5 mg (V80A5) comparado a anlodipino (A5) isoladamente, em dose única diária, em uma população de pacientes portadores de hipertensão arterial leve a moderada. Este estudo foi realizado em 24 centros de pesquisa no Brasil. Pacientes com idade entre 21 e 70 anos, com diagnóstico de hipertensão arterial essencial (PA diastólica média na posição sentada [PADMS] ≥ 95 mmHg e < 110 mmHg), foram elegíveis. Após um período de wash-out de 2 semanas, os pacientes foram randomizados para receber V80/A5 ou A5 isoladamente, uma vez ao dia, em um estudo multicêntrico, aberto, randomizado, comparativo, de grupos paralelos, com um período de tratamento ativo de 8 semanas. O desfecho primário foi a variação em relação ao basal na PADMS. Os desfechos secundários foram a média da PA sistólica na posição sentada (PASMS), taxa de resposta, PA sistólica e a diastólica médias na posição ortostática. As avaliações de segurança incluíram a incidência e gravidade dos eventos adversos relacionados ao tratamento relatados durante o estudo. A população da análise intenção de tratar (ITT) consistiu em 273 pacientes (V80A5, 88 homens, 185 mulheres; idade média [DP] de 54,0 [9,6] anos; e Recebido: 16/3/2007 Aceito: 19/4/2007 276 pacientes [A5], 95 homens, 181 mulheres; idade média[DP] de 54,2 [9,4] anos). No grupo V80A5, os valores da média da PAS e PAD (DP) foram, respectivamente, 155,8 (11,8) e 100,3 (3,8) mmHg no basal e 131,9 (14,5) e 84,8(8,6) mmHg ao final do período de tratamento. No grupo A5, as médias da PAS e PAD (DP) foram, respectivamente, 154,2 (11,4) e 99,9 (3,4) mmHg no basal e 134,4 (12,8) e 86,0(7,6) mmHg ao final do período de tratamento.

Prediction of cardiovascular outcome by estimated glomerular filtration rate and estimated creatinine clearance in the high-risk hypertension population of the VALUE trial.

BACKGROUND: Reduced renal function is predictive of poor cardiovascular outcomes but the predictive value of different measures of renal function is uncertain. METHODS: We compared the value of estimated creatinine clearance, using the Cockcroft-Gault formula, with that of estimated glomerular filtration rate (GFR), using the Modification of Diet in Renal Disease (MDRD) formula, as predictors of cardiovascular outcome in 15 245 high-risk hypertensive participants in the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial. For the primary end-point, the three secondary end-points and for all-cause death, outcomes were compared for individuals with baseline estimated creatinine clearance and estimated GFR < 60 ml/min and > or = 60 ml/min using hazard ratios and 95% confidence intervals. Coronary heart disease, left ventricular hypertrophy, age, sex and treatment effects were included as covariates in the model. RESULTS: For each end-point considered, the risk in individuals with poor renal function at baseline was greater than in those with better renal function. Estimated creatinine clearance (Cockcroft-Gault) was significantly predictive only of all-cause death [hazard ratio = 1.223, 95% confidence interval (CI) = 1.076-1.390; P = 0.0021] whereas estimated GFR was predictive of all outcomes except stroke. Hazard ratios (95% CIs) for estimated GFR were: primary cardiac end-point, 1.497 (1.332-1.682), P < 0.0001; myocardial infarction, 1.501 (1.254-1.796), P < 0.0001; congestive heart failure, 1.699 (1.435-2.013), P < 0.0001; stroke, 1.152 (0.952-1.394) P = 0.1452; and all-cause death, 1.231 (1.098-1.380), P = 0.0004. CONCLUSION: These results indicate that estimated glomerular filtration rate calculated with the MDRD formula is more informative than estimated creatinine clearance (Cockcroft-Gault) in the prediction of cardiovascular outcomes.

The homeopathic antiarthitic preparation Zeel comp. N: a review of molecular and clinical data.

Zeel comp. N (Zeel) is a homeopathic medication that has been widely used for many years for the treatment of arthritic disorders in a large number of countries worldwide. In recent years, a growing body of clinical and molecular evidence has been accumulating that shed light on the possible antiarthritic effects of this preparation. A number of studies report anti-inflammatory effects from Zeel. In vitro studies have indicated Zeel-mediated inhibition of the pathways involving the enzymes cyclooxygenase-1 and -2, and also the 5-lipoxygenase pathways, affecting levels of both eicosanoids and leukotrienes. Thus, Zeel may reduce the main two classes of molecules responsible for arthritic pain and inflammation. This review describes recent research on Zeel and discusses the need for further studies to clarify the role of the compound in the antiarthritic armamentarium of complementary medicine.

Effects of valsartan compared to amlodipine on preventing type 2 diabetes in high-risk hypertensive patients: the VALUE trial.

CONTEXT: Type 2 diabetes is emerging as a major health problem, which tends to cluster with hypertension in individuals at high risk of cardiovascular disease. OBJECTIVE: To test for the first time the hypothesis that treatment of hypertensive patients at high cardiovascular risk with the angiotensin-receptor blocker (ARB) valsartan prevents new-onset type 2 diabetes compared with the metabolically neutral calcium-channel antagonist (CCA) amlodipine. DESIGN: Pre-specified analysis in the VALUE trial. Follow-up averaged 4.2 years. The risk of developing new diabetes was calculated as an odds ratio (OR) with 95% confidence intervals (CI) for different definitions of diabetes. PATIENTS: A sample of 9995 high-risk, non-diabetic hypertensive patients. INTERVENTIONS: Valsartan or amlodipine with or without add-on medication [hydrochlorothiazide (HCTZ) and other add-ons, excluding other ARBs, angiotensin-converting enzyme (ACE) inhibitors, CCAs]. MAIN OUTCOME MEASURE: New diabetes defined as an adverse event, new blood-glucose-lowering drugs and/or fasting glucose > 7.0 mmol/l. RESULTS: New diabetes was reported in 580 (11.5%) patients on valsartan and in 718 (14.5%) patients on amlodipine (OR 0.77, 95% CI 0.69-0.87, P < 0.0001). Using stricter criteria (without adverse event reports) new diabetes was detected in 495 (9.8%) patients on valsartan and in 586 (11.8%) on amlodipine (OR 0.82, 95% CI 0.72-0.93, P = 0.0015). CONCLUSION: Compared with amlodipine, valsartan reduces the risk of developing diabetes mellitus in high-risk hypertensive patients.

Antiviral activity of Engystol: an in vitro analysis.

OBJECTIVES: To study the effects of the homeopathic preparation Engystol (Biologische Heilmittel HEEL GmbH, Baden-Baden, Germany) on a panel [corrected] of human pathogenic viruses in vitro. DESIGN: The effects of Engystol were studied using plaque-reduction assays and virus titration assays, and by quantification of newly synthesized viral proteins in virus-specific enzyme-linked immunoabsorbent assays (ELISAs). SUBJECTS: The DNA viruses Adeno 5 and herpes simplex type 1 (HSV-1), the RNA virus respiratory syncytial virus (RSV), and human rhinovirus (HRV). RESULTS: A 73% reduction of Adeno 5 specific proteins and an 80% reduction in HSV-1 specific proteins were observed in ELISAs of virus-infected cells treated with Engystol after infection. The effects appeared to be dose-dependent. With these viruses, similar results were observed in titration assays of viral offspring from cells treated with Engystol. Pretreatment of adenovirus with Engystol did not inhibit the infectivity of the virus suspension and no Engystol-induced stimulation of interferon-alpha could be observed. Plaque-reduction assays with the RNA viruses, RSV and HRV, showed reductions in infectivity by 37% (RSV) and 20% (HRV), respectively. CONCLUSIONS: The results indicate antiviral activity of Engystol independent of the activation of the cellular interferon system.

Antihypertensive efficacy and tolerability of two fixed-dose combinations of valsartan and hydrochlorothiazide compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension: an 8-week, randomized, double-blind, parallel-group trial.

BACKGROUND: Combination therapy with at least 2 antihypertensive agents is usually needed to achieve appropriate blood pressure (BP) control in patients with isolated or predominant systolic hypertension. A currently recommended combination is a diuretic added to an angiotensin-receptor blocker. OBJECTIVE: This was a study of the effects on sitting systolic BP (SBP)of 2 combinations of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension (SBP > or =160 mm Hg and < or =200 mm Hg) with or without other cardiovascular risk factors. METHODS: After a placebo run-in period, patients were randomized to receive double-blind treatment with either valsartan 80 mg OD(monotherapy group) or valsartan 160 mg OD (combination-therapy groups) for 4 weeks, followed by forced titration to valsartan 160 mg OD (V160), valsartan 160 mg plus HCTZ 12.5 mg OD (V160 +HCTZ12.5), or valsartan 160 mg plus HCTZ 25 mg OD (V160 +HCTZ25) for an additional 4 weeks. End points were the change in SBP between the groups receiving combination therapy and the monotherapy group, between-group changes in diastolic BP (DBP), responder rates (SBP <140 mm Hg or a reduction in SBP of > or =20 mm Hg), and tolerability. RESULTS: A total of 774 patients were randomized to treatment: 261 to V160, 258 to V160+HCTZ12.5, and 255 to V160 +HCTZ25. The intent-to-treat population consisted of 767 patients (411 men, 356 women; mean age, 60 years; mean weight, 84 kg; clinic mean [SD] baseline BP, 167.5 [8.1]/93.4 [9.1] mm Hg). All treatments produced significant reductions in SBP from baseline (mean [SD] reduction, 20.7 [15.7] mm Hg with V160, 27.9 [13.8] mm Hg with V160 +HCTZ12.5, and 28.3 [13.1] mm Hg with V160+HCTZ25; all, P < 0.05). DBP was reduced by 6.6 (8.9) mm Hg in the V160 group and by 10.2 (7.7) and 10.1 (7.8) mm Hg in the V160+HCTZ12.5 and V160 +HCTZ25 groups, respectively (all, P < 0.05). The additional reductions in BP with V160+HCTZ25 did not reach statistical significance compared with V160+HCTZ12.5. Responder rates were 56.9% in the V160 group, 74.4% in the V160+HCTZ12.5 group, and 75.0% in the V160 +HCTZ25 group P < 0.05, combination therapy vs monotherapy). Adverse events were reported by 27.5% of patients in the monotherapy group, compared with 28.6% and 34.0% in the groups that received V160+HCTZ12.5 and V160+HCTZ25, respectively; the differences were not significant between treatment groups. CONCLUSIONS: Monotherapy with V160 was effective in these patients with stage 2 or 3 systolic hypertension. Significant additional reductions in SBP and DBP and an increase in responder rates were achieved with the addition to V160 of HCTZ12.5 and HCTZ25, with no significant effect on tolerability.

24-hour ambulatory blood-pressure effects of valsartan and hydrochlorothiazide combinations compared with amlodipine in hypertensive patients at increased cardiovascular risk: a VAST sub-study.

BACKGROUND: There is a lack of data on the effects of angiotensin-receptor blocker and diuretic combinations on ambulatory blood pressure (ABP) in hypertensive patients with additional cardiovascular risk factors. METHODS: In a randomized, double-blind trial, the effects on 24-h ABP of the combination valsartan 160 mg od and hydrochlorothiazide 25 or 12.5 mg during 24 weeks of therapy were compared with the effects of amlodipine 10 mg monotherapy (group A10) in 474 stage-II hypertensive patients with additional cardiovascular risk factors. After a two-week single-blind placebo run-in period, patients were randomized to receive valsartan 160 mg od or amlodipine 5 mg od. At week 4, HCTZ 12.5 mg (group V160/HCTZ12.5) and 25 mg (group V160/HCTZ25) were added to the valsartan groups and in the A10 patients the amlodipine dose was force-titrated to 10 mg od. RESULTS: All three treatments reduced 24-h BP as well as night-time and daytime BP levels from baseline. Twenty-four hour systolic blood pressure (SBP) was reduced by 15.9+/-1.0 mmHg (least-squares mean change+/-SE), 19.3+/-1.0 mmHg and 16.1+/-1.1 mmHg in the V160/HCTZ12.5, V160/HCTZ25 and A10 groups, respectively and 24-h diastolic blood pressure (DBP) was reduced by 9.3+/-0.6 mmHg, 11.4+/-0.6 mmHg and 9.6+/-0.7 mmHg in the three groups. The differences between the V160/HCTZ25 group and the A10 group were significant (p<0.05) for the changes in 24-h systolic BP as well as for changes in daytime systolic BP and night-time diastolic BP. Control rates defined as ABPM < or =130/80 mmHg were: 48.4%, 60.8% and 50.9% in the V160/HCTZ12.5, V160/25 and A10 groups, respectively. The differences in control rates between the V160/HCTZ25 group and the other two treatment groups were significant at p<0.05. CONCLUSIONS: The fixed-dose combination of valsartan 160 mg+HCTZ 25 mg od is an attractive therapeutic option measured on the effects on 24-h ABPM, night-time and daytime BP reduction and control rates in hypertensive patients at additional cardiovascular risk.

A homeopathic ointment preparation compared with 1% diclofenac gel for acute symptomatic treatment of tendinopathy.

CONTEXT: The incidence of tendon injuries and tendinopathy has risen substantially in the past decades. OBJECTIVE: To assess the noninferiority of therapy based on the homeopathic preparation Traumeel S ointment (Heel GmbH, Baden-Baden, Germany) compared with treatment based on diclofenac 1% gel in patients with tendinopathies of varying etiology. DESIGN: Nonrandomized, observational study. SETTING: Ninety-five homeopathy and conventional medical practices in Germany. PATIENTS: Three hundred fifty-seven patients aged 18 to 93 years with tendinopathy of varying etiology based on excessive tendon load rather than inflammation. INTERVENTIONS: Traumeel S ointment or diclofenac 1% gel for a maximum of 28 days. MAIN OUTCOME MEASURES: Efficacy was measured on a four-degree scale on pain-related variables, on variables related to motility, and on overall treatment outcome. Tolerability was monitored as adverse events. Compliance was assessed by practitioner and patient on a four-degree scale. RESULTS: The patients groups were comparable at baseline. The changes in summary score of all pain-related variables were -5.3 +/- 2.7 (all values means +/- SD) in the Traumeel group and -5.0 +/- 2.7 in the control group. Changes for all motility-related variables were -4.2 +/- 3.8 with Traumeel and -3.7 +/- 3.4 with control therapy. The summary scores for all clinical variables were reduced by -9.5 +/- 5.7 with Traumeel therapy and by -8.7 +/- 5.4 with diclofenac-based treatment. Homeopathic therapy was noninferior to diclofenac therapy on all variables. For motility-related variables, there was a trend toward superiority of Traumeel. Treatments were well tolerated with no treatment-related adverse events. CONCLUSIONS: The results suggest that Traumeel ointment is an effective alternative to nonsteroidal antiinflammatory drugs therapy for the acute symptomatic treatment of patients with tendinopathy.